Prospective follow-up of the Prevision hip stem with comparison of implant variants
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
This project will test whether adults receiving the Prevision revision hip stem have similar two-year hip function and safety as those who received the previous implant generation or comparable revision stems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 2 sites (Hanover and 1 other locations) |
| Trial ID | NCT06626490 on ClinicalTrials.gov |
What this trial studies
This is an observational post‑market follow-up of patients treated with the Prevision revision hip stem, designed as a non‑inferiority comparison of two‑year functional outcomes measured by the Oxford Hip Score (OHS) against the predecessor implant generation and comparable revision stems. Study sites choose which Prevision variant to implant according to routine practice, with all variants available and switching between variants encouraged. The primary focus is patient‑reported function at two years, with descriptive comparisons of subgroups treated with different stem variants and systematic collection of clinical performance and safety data. No randomized assignment is used; outcomes reflect real‑world use across participating orthopedic centers.
Who should consider this trial
Good fit: Adults undergoing revision total hip arthroplasty who receive a Prevision revision stem, can give written informed consent, and are able to attend follow‑up visits are eligible.
Not a fit: Patients under 18, those who are pregnant, held in custody, in a dependent relationship with the sponsor/clinic/investigator, or unable to attend follow‑up visits are not expected to benefit from participation.
Why it matters
Potential benefit: If successful, the results could confirm that the Prevision family provides comparable two‑year hip function and safety, giving surgeons flexible implant options with consistent patient outcomes.
How similar studies have performed: Modular and variant revision hip stems have been used in clinical practice with generally acceptable outcomes, but this observational follow‑up specifically aims to confirm non‑inferiority for the Prevision family.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Revision hip arthroplasty patients treated with a Prevision hip stem * Written patient informed consent * Patients are able to attend at follow-up examinations Exclusion Criteria: * Patients \< 18 years at surgery * Pregnancy at implantation * Patients held in a custodial setting * Patients in a relationship of dependence on the sponsor, the clinic or the investigator
Where this trial is running
Hanover and 1 other locations
- Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7 — Hanover, Germany (Recruiting)
- Hinchingbrooke Hospital — Huntingdon, Cambridgeshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Henning Windhagen, Prof. Dr. — Orthopädische Kliniken im Annastift, MHH
- Study coordinator: Kerstin Bergmann
- Email: studies@aesculap.de
- Phone: +49746195-
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.